Nichols v. McNeilab, Inc.

850 F. Supp. 562, 1993 U.S. Dist. LEXIS 15769, 1993 WL 642808
CourtDistrict Court, E.D. Michigan
DecidedOctober 13, 1993
Docket4:87-cv-40380
StatusPublished
Cited by5 cases

This text of 850 F. Supp. 562 (Nichols v. McNeilab, Inc.) is published on Counsel Stack Legal Research, covering District Court, E.D. Michigan primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Nichols v. McNeilab, Inc., 850 F. Supp. 562, 1993 U.S. Dist. LEXIS 15769, 1993 WL 642808 (E.D. Mich. 1993).

Opinion

MEMORANDUM OPINION AND ORDER

NEWBLATT, District Judge.

Before the Court is defendants’ motion for summary judgment (D.E.#235), plaintiffs response, and defendants’ reply. For the reasons that follow, defendants’ motion is DENIED.

This wrongful death action arises out of the death of Twila Ann Nichols (“decedent”) on December 21, 1984. Plaintiff alleges that the cause of decedent’s death was a severe anaphylactic reaction to the ingestion of Zomax, a prescription drug manufactured and marketed by defendants. Through their motion, defendants seek summary judgment on plaintiffs claim against defendants for breach of a duty to adequately warn Zomax consumers of the drug’s withdrawal from the market due to possible anaphylactic reactions to its use by some patients. Defendants contend that pursuant to the “learned intermediary rule,” defendants complied with any duty they had to warn decedent by warning prescribing physicians of the dangers of the drug and of its withdrawal from the market in March 1983, and recommending that those physicians direct their patients to discontinue use of the drug. While the parties dispute the means and sufficiency of the warnings given to physicians and the adequacy of any warning to consumers via press releases publicizing the drug’s withdrawal, neither the means used nor the adequacy of the warnmgs are relevant to resolution of defendants’ motion. 1 The sole question posed by defendants’ motion for summary judgment is whether defendants’ actions were sufficient to discharge their duty to warn as a matter of law. The Court, after great consideration, finds that they were not.

Facts and Procedural History

The relevant facts of this case have been set forth in both the Magistrate Judge’s Report and Recommendation of June 6, 1990 (D.E. # 107), and a Report and Recommendation (“R & R”) filed September 30, 1992 (D.E. # 224). The relevant portions of these R & Rs have been adopted as the opinion of this Court. Therefore, it is unnecessary to repeat the facts; rather, the Court hereby incorporates by reference the fact pattern as recounted in the above-mentioned R & Rs.

In addition to setting forth a detailed factual description regarding this matter, in his R & R of June 6, 1990 the Magistrate Judge addressed defendants’ motion, which argued that, inter alia, defendants satisfied their duty to warn by notifying physicians generally about the risks attendant with Zomax use and withdrawing the drug from the market in a highly publicized manner. The Magistrate Judge analyzed the law in this area, and recommended denial of defendants’ motion as to this claim because of the parties’ failure “to discuss whether a manufacturer of a product ... has an enhanced duty to warn the consuming public directly of its product’s dangers once it finds it necessary to withdraw that product from the market.” June 6, 1990 R & R at 15. The Magistrate Judge recommended denial of defendants’ motion without prejudice, inviting defendants to readdress the duty to warn issues. Id. at 17. As noted above, the Court accepted the Magistrate Judge’s R & R, thus leaving open the door to defendants’ present motion for summary judgment. Unfortunately for defendants, they have failed to cite additional case law in support of their contention that their duty to warn was discharged pursuant to the learned intermediary doctrine. Moreover, *564 their arguments directed toward the issue are unpersuasive.

Discussion

At the outset, the Court further refers the parties to the Magistrate Judge’s discussion and analysis regarding the learned intermediary doctrine as it is set forth in the June 6, 1990 R & R at pages twelve through sixteen. The Court finds this discussion applicable to defendants’ present motion and, to the extent applicable, the Court adopts that reasoning herein. In the motion now before the Court, defendants add little to their argument as addressed and disposed of by the June 6, 1990 R & R. To the extent that defendants do expand their argument on the issue, the Court finds it unpersuasive. Accordingly, summary judgment is again denied at this time.

Instead of providing further case law in support of their position, defendants argue that “[n]o court has ever imposed a duty to warn patients directly because the nature of the warning was an explicit directive to discontinue use of a prescription drug.” Defendants’ motion brief at 10. Defendants argue that because decedent’s physicians had been informed, decedent’s failure to indicate to those physicians that she was taking Zomax entitles defendants to summary judgment. Defendants reason that the learned intermediary doctrine would have prevented decedent’s death but for her negligent behavior. This assertion, however, provides support not for summary judgment, but rather for the defense of comparative negligence that may be argued to a jury. Upon the facts of this case, the Court finds the learned intermediary doctrine inapplicable.

The learned intermediary doctrine is an exception carved out of the general rule that it is a manufacturer’s duty to warn its product’s users of dangers known to be inherent in the product. As applied to prescription drugs, the doctrine shifts the manufacturer’s duty from requiring a warning directly to the consumer/patient to requiring that a warning be communicated to the physician, who is in a better position to weigh the risks and benefits of the use of the drug. The rationale behind the doctrine is that, in making the determination as to whether the treatment of a patient should include the prescription of a manufacturer’s drug, the physician, acting as a learned intermediary, is in a better position not only to weigh the risks and benefits of the particular drug for the particular patient, but also to explain these risks and benefits to the patient herself. The presumption is that use of the learned intermediary to convey the necessary warnings and recommendations is more effective and safe than would be any communication directly between a manufacturer and the consumer. While this doctrine holds true for the prescription of prescription drugs, to which the consumer has no access except through her physician, it is questionable whether this approach reasonably and adequately provides notice to a consumer of the recall or withdrawal of a prescription drug that is used on an intermittent basis by the consumer. 2

This is the very point made by the Magistrate Judge in his June 6, 1990 R & R, and is the issue in support of which defendants were invited to provide additional law and argument. Instead of citing additional case law in support of their position, defendants have merely argued that there is no distinction between the facts of this case— the withdrawal of a prescription drug from the market — and the classic case — in which the physician makes a decision as to whether a patient’s treatment requires prescription of a certain drug and gives instructions as to its use to the patient. The Court, as did the Magistrate Judge, does see a distinction, and finds that reliance upon a warning to a learned intermediary in this case may not discharge defendants’ duty to adequately warn as a matter of law.

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Cite This Page — Counsel Stack

Bluebook (online)
850 F. Supp. 562, 1993 U.S. Dist. LEXIS 15769, 1993 WL 642808, Counsel Stack Legal Research, https://law.counselstack.com/opinion/nichols-v-mcneilab-inc-mied-1993.